MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).Maquet (b)(4) requested the product back for investigation but it has not been received.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.Additional information: the product mentioned under section d is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.

Event Description

Description from the customer report: day 7 vv-ecls support.Customer noted sudden increase of delta pressure from 16 to >200mmhg.4l/min flow @ 3500 rpm.Gas exchange adequate.Act-171 sec.Customer concerned with sudden thrombus development within membrane.No visible clot noted.The circuit was exchanged for a new primed circuit due to increase of delta p.There was no consequence to the patient.(b)(4).

Manufacturer Narrative

The product was tested with bovine blood for its o2 & co2 transfer rates as well of it pressure drop behaviour at maximum flow.The product was operating within the acceptance criterias and therefore passed the test.No abnormalities were detected, the product operated according to its specifications.Thus the reported failure could not be confirmed.The most probable cause of the reported failure is unknown.Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5644148
• MDR Text Key: 45484715
• Report Number: 8010762-2016-00329
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70110231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1